Catalog Number 112016 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Oxiris has been temporarily approved for use in the us under emergency use authorization eua(b)(4) with a specific indication to treat patients with covid-19 infection.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during priming with an oxiris set, the screwed connector (the rigid component that connects the filter to the return line) was observed to be cracked and was leaking.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.An air leak pressure test was performed and a leak at the level of the filter blood header was observed.There was a crack on the port of the filter blood header.The reported condition was verified.The cause is shipping and transportation related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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